Today is 2019-12-14

Evaluation Effects and Safety of Using Lower Dose CTA Scan Protocol Diagnosis on Patients with the Low Extremity Peripheral Artery Disease and Chronic Kidney Disease with Contrast Induced-Acute Kidney Injury’s Risk Factor
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注册号:

Registration number:

ChiCTR1900027602 

最近更新日期:

Date of Last Refreshed on:

2019-11-23 

注册时间:

Date of Registration:

2019-11-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

评价低剂量CTA扫描方案诊断下肢动脉血管狭窄伴慢性肾病且存在对比剂肾病高危因素患者的诊断效果和安全性获益 

Public title:

Evaluation Effects and Safety of Using Lower Dose CTA Scan Protocol Diagnosis on Patients with the Low Extremity Peripheral Artery Disease and Chronic Kidney Disease with Contrast Induced-Acute Kidney Injury’s Risk Factor 

注册题目简写:

LCTA-PAD Study 

English Acronym:

 

研究课题的正式科学名称:

评价低剂量CTA扫描方案诊断下肢动脉血管狭窄伴慢性肾病且存在对比剂肾病高危因素患者的诊断效果和安全性获益 

Scientific title:

Evaluation Effects and Safety of Using Lower Dose CTA Scan Protocol Diagnosis on Patients with the Low Extremity Peripheral Artery Disease and Chronic Kidney Disease with Contrast Induced-Acute Kidney Injury’s Risk Factor 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

程莉园 

研究负责人:

吴磊 

Applicant:

Liyuan Cheng 

Study leader:

Lei Wu 

申请注册联系人电话:

Applicant telephone:

+86 15972088874 

研究负责人电话:

Study leader's telephone:

+86 15071343665 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

64136079@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

cookiebag@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

江苏南京市栖霞区恒广路99号 

研究负责人通讯地址:

湖北省十堰市茅箭区人民南路32号 

Applicant address:

99 Hengguang Road, Qixia District, Nanjing, Jiangsu, China 

Study leader's address:

32 South Renmin Road South, Maojian District, Shiyan, Hubei, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

南京正大天晴制药有限公司 

Applicant's institution:

Nanjing Chia Tai TIanqing Pharmaceutical Co., Ltd. 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

科研会审(201931)号 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

太和医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Taihe Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-11-01 

伦理委员会联系人:

简钢 

Contact Name of the ethic committee:

Gang Jian 

伦理委员会联系地址:

湖北省十堰市茅箭区人民南路32号十堰市太和医院 敬业楼 

Contact Address of the ethic committee:

32 South Renmin Road South, Maojian District, Shiyan, Hubei, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

十堰市太和医院 

Primary sponsor:

Shiyan Taihe Hospital 

研究实施负责(组长)单位地址:

湖北省十堰市茅箭区人民南路32号 

Primary sponsor's address:

32 South Renmin Road South, Maojian District, Shiyan, Hubei  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖北省

市(区县):

十堰市

Country:

China

Province:

Hubei

City:

Shiyan

单位(医院):

十堰市太和医院

具体地址:

茅箭区人民南路32号

Institution
hospital:

Shiyan Taihe Hospital

Address:

32 Renmin Road, Maojian District

经费或物资来源:

十堰市太和医院 

Source(s) of funding:

Shiyan Taihe Hospital 

研究疾病:

下肢动脉血管狭窄伴慢性肾病 

Target disease:

Lower limb artery stenosis with chronic kidney disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

初步探索低剂量CTA、标准剂量CTA和DSA用于下肢动脉粥样硬化导致下肢动脉狭窄或闭塞诊断效果; 初步评估低剂量CTA较标准剂量CTA对下肢动脉粥样硬化导致下肢动脉狭窄/闭塞伴慢性肾病(eGFR<60)同时伴随CIN高危因素患者的肌酐影响。 

Objectives of Study:

The diagnostic effects of low-dose CTA, standard dose CTA and DSA on lower limb artery stenosis or occlusion caused by atherosclerosis were preliminarily explored. Preliminary assessment of creatinine effects of low-dose CTA compared with standard dose CTA on lower limb atherosclerosis leading to lower limb arterial stenosis/occlusion with chronic kidney disease (eGFR < 60) and CIN risk factors. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

ABI(Ankle-Brachial Index)筛选和诊断确定PAD患者; 超声检查存在50%以上狭窄且有必要进行CTA诊断; Fontaine分级为Ⅲ-Ⅳ级或静息痛期-坏趾期; 经30ml/min/1.73m2

Inclusion criteria

1. Sorting out and diagnosing PAD patients according to the no-abi (ankle-brachial Index); 2. Ultrasonic examination has more than 50% stenosis and CTA diagnosis is necessary; 3. Argument Fontaine class for III-IV and resting stage pain - bad toe; 4. Mm2ckd patients with mber of 30ml/min/1.73m2; 5. Is accompanied by any of the following high-risk factors of CIN; 6. High blood pressure; 7. Intra-aortic balloon; 8. Congestive heart failure; 9. Aged >=75 years; 10. anemia; 11. diabetes; 12. Sign informed consent. 

排除标准:

DSA、CTA和碘对比剂禁忌症; 需要紧急医学处理的急性梗死; 孕妇、儿童(<16岁) 生存期<6个月; 伴有需要腔内手术治疗的心肌梗死和脑梗死; 7天内进行过对比剂增强检查; 

Exclusion criteria:

1. Contraindications of DSA, CTA and iodine contrast agent; 2. Acute infarction requiring urgent medical treatment; 3. Pregnant women and children (< 16 years old); 4. Survival period < 6 months; 5. Accompanied by myocardial infarction and cerebral infarction requiring intracavitary surgery; 6. Contrast-enhanced examination was conducted within 7 days. 

研究实施时间:

Study execute time:

From2019-11-18To 2020-12-31 

诊断措施:

Diagnostic measures:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

DSA

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

DSA

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

低剂量CTA、标准剂量CTA

Index test:

Low dose CTA, and standard dose CTA

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

下肢动脉狭窄伴CKD存在CIN高危因素患者

例数:

Sample size:

155

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Patients with lower extremity artery stenosis with high risk factors of CIN associated with CKD

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

十堰 

Country:

China 

Province:

Hubei 

City:

Shiyan 

单位(医院):

十堰市太和医院 

单位级别:

三级甲等 

Institution
hospital:

Shiyan Taihe Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

图像质量(4级评分法)

指标类型:

主要指标 

Outcome:

Image quality (grade 4)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌酐值

指标类型:

主要指标 

Outcome:

Creatinine values

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

N/A

Randomization Procedure (please state who generates the random number sequence and by what method):

N/A

盲法:

未说明

Blinding:

Not stated

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

试验完成后6个月 内部数据库

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Internal database 6 months after trial completion

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

病例记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-11-20
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